FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3950078
·
Received July 22, 2014
Report
- Report Number
- 3004209178-2014-13352
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Report Date
- June 30, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V796194, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT STARTING 2 MONTHS AGO THE PATIENT BEGAN TO HAVE PAINFUL STIMULATION. THE PAINFUL STIMULATION CAME ON SUDDENLY AND THE PATIENT DIDN¿T ALLUDE TO ANYTHING PROMPTING IT. IT WAS NOTED THAT THE PATIENT¿S HEALTH CARE PROVIDER (HCP) WAS INTERROGATING THE IMPLANT AND THE PATIENT HAD BEEN ON PROGRAM 2 99 PERCENT OF THE TIME AND HAD TRIED TO TURN STIMULATION DOWN BUT THAT DIDN¿T HELP. THE PATIENT HAD NOT COMMUNICATED THE ISSUE TO THEIR FOLLOW-UP HCP. IT WAS REPORTED THAT PROGRAM 2 WAS SET USING 3 POSITIVE AND 2 NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428541 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |